MAUDE Adverse Event Report: COSMAN MEDICAL NITINOL TC ELECTRODE

Model Number	TCN-15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Device evaluation performed on the returned electrode revealed that the shaft was broken off from the hub.

• Brand Name: NITINOL TC ELECTRODE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 6820888
• Report Number: 3006630150-2017-03196
• Device Sequence Number: 68604
• Product Code: GXI
• UDI-Device Identifier: 00813250013061
• UDI-Public: 00813250013061
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K050084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: TCN-15
• Device Lot Number: 060416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1